BEUDAMED
    FDA Adverse Event Other Summary report: N

    TRACH CARE CLOSED SUCTION FOR PEDIATRICS 8 F

    MDR report key: 1292255 · Received January 13, 2009

    Report

    Report Number
    8030647-2009-00001
    Event Type
    Other
    Date Received
    January 13, 2009
    Date of Event
    December 9, 2008
    Report Date
    January 8, 2009
    Manufacturer
    AVENT S. DE R.L. DE C.V.
    Product Code
    BSY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INCIDENT SAMPLE HAS NOT YET BEEN RECEIVED, PHOTOGRAPHS OF THE SUBJECT DEVICE HAVE BEEN RECEIVED AND ARE BEING EVALUATED. IT SHOULD BE NOTED THAT IN THE PRODUCT'S DIRECTIONS FOR USE, THE WARNING LABEL CLEARLY STATES, "FULLY WITHDRAW TRACH CARE CATHETER BEFORE CUTTING ENDOTRACHEAL TUBE, OTHERWISE THE CATHETER MAY ALSO BE CUT." A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON RECEIPT OF ADDITIONAL RELEVANT INFORMATION. INFORMATION FROM THIS INCIDENT WILL BE INCLUDED IN OUR PRODUCT COMPLAINT AND MDR TREND REPORTING SYSTEMS. ONGOING ANALYSIS OF TREND INFORMATION IS USED TO IDENTIFY THE NEED FOR ADDITIONAL INVESTIGATIONS.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED BY A USER HOSPITAL THAT THE TIP OF THE CATHETER HAD ALLEGEDLY COME OUT OF THE PT'S ENDOTRACHEAL TUBE. THE USERS STATED THAT THEY REMOVED THE TRACH CARE DEVICE WHEN THEY CUT THE ENDOTRACHEAL TUBE. THERE WERE NO REPORTS OF ANY INJURIES OR DEATH AS A RESULT OF THIS ALLEGED PRODUCT PROBLEM. KIMBERLY-CLARK HAS NO INDEPENDENT KNOWLEDGE OF THE EVENT REPORTED, BUT IS RELAYING THE INFORMATION THAT WAS PROVIDED BY THE USER FACILITY WHERE THE INCIDENT OCCURRED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRACH CARE CLOSED SUCTION FOR PEDIATRICS 8 F TRACH CARE BSY AVENT S. DE R.L. DE C.V. 437832

    Patients

    Seq Age Sex Outcome Treatment
    1